Below is a message from PANDORA, a nonprofit patient advocacy group for people with neuro-endocrine-immune illnessses. (That's us!)

It takes less than a minute to send the email. I just did it!

Public pressure really does work. Silence doesn't.

Attention ME/CFS patient community,The email campaign to the FDA is continuing. We are asking them to fulfill the promises and purpose of their April ME/CFS Drug Development workshop.Now is not the time to give up!Patient advocates have been visiting Washington legislators in the last few weeks. This is going to add even more pressure. But, they need to know patients care about this issue. Medical professionals are telling us that when one drug is approved for this disease, other companies will take an interest.

PANDORA Org and the rest of the "FDA Team" are asking you to send a new message to the FDA and to listed members of Congress. We want them to hear from you, your family and your friends.

Remember, NUMBERS COUNT! Please email the following to David Banks, who monitors the emails for Dr. Janet Woodcock, and PANDORA Org. (We are also monitoring how many emails are sent.) Additionally, please Cc others in the Department of Health and Human Services and congressional staff members so they can influence the FDA.Just copy and paste the following, filling in your name and address or email information at the end. (As always, this is just a suggested template for your convenience):--- ---To: David.Banks@fda.hhs.gov, info@pandoraorg.netCc: howard.koh@hhs.gov, Sara_Mabry@casey.senate.gov, Karen_Wade@hagan.senate.gov, Eamonn_Hart@blumenthal.senate.gov, Carolyn_gluck@reid.senate.gov, monica.volante@mail.house.gov, robb.walton@mail.house.gov, rebekah.armstrong@mail.house.gov, eric.fox@mail.house.gov, christopher.Stewart@mail.house.gov, ryan.mcBride@mail.house.govSubject: ME/CFS TreatmentsDear Drs. Hamburg and Woodcock:ME/CFS patients continue to suffer day after day, year after year. You can change that by working directly with the pharmaceutical industry. Give us the opportunity to have some quality of life.You have often said you are committed to those suffering from chronic diseases, acknowledging the burden to our nation's families, healthcare system and economy. The way the FDA has dealt with diseases like Alzheimer's and obesity demonstrates you can and are willing to create a special pathway to drug development for chronic diseases with high morbidity.No drug is without risk. No drug works on every patient. But physicians and ME/CFS patients have no options. When there are NO drugs approved for a disease, there is NO innovation by pharma and NO hope for those suffering.As physicians, you understand the risk vs. benefit, especially for diseases that create high morbidity. As leaders, you have the ability to change the lives of those suffering with ME/CFS. Over 700 patients provided testimony to the advisory committee supporting Ampligen, and more than 4,000 patients asked you to approve the drug. The top two potential drugs, Ampligen and Rituxmab, did not make the agenda at the Patient Focused Drug Development Workshop. Key words here: DRUG DEVELOPMENT. Their manufacturers were not even invited to the FDA's Drug Development meeting.We know these drugs and others have the potential to help some patients with ME/CFS. We understand greater than anyone the risks and benefits of living with ME/CFS. Bring pharma - all those companies that have drugs that are now being used off label for ME/CFS patients - to the table! Without such a meeting, those in charge of overseeing drug development for ME/CFS are simply spouting empty words of "support."

"If there is any disease cohort that needs this kind of jumpstart funding, it is the ME/CFS community," Jennie Spotila.

Eleven ME/CFS organizations, including A Race to Solve CFS, CFIDS Self Help, CFIDS Association of America, CFS Knowledge Center, Fibromyalgia-ME/CFS Support Center, Inc., Health Rising, Massachusetts CFIDS/ME & FM Association, OFFER, PatientsLikeMe, Rocky Mountain CFS/ ME & FM Association and Speak Up About ME are competing for $12 million that will fund up to 18 Patient-Powered Research Networks. These 18 Patient-Powered Research Networks will serve as the basic building blocks for a National Patient-Centered Clinical Research Network. This is a tremendous opportunity for the ME/CFS and Fibromyalgia community!

The National Patient-Centered Clinical Research Network will improve our nation’s capacity to conduct research effectively and efficiently. Having ME/CFS and Fibromyalgia in this National framework ‘mainstreams’ research on our disease and will attract the best and brightest investigators. This will give us ample opportunity to not only participate in ME/CFS and Fibromyalgia research but also to enter into the conversation about the types of research that should be done.

Part of the application requires that we describe some basic aspects of our community. If you live in the U.S. and you are a CFS, ME, or Fibromyalgia patient, please take a moment to answer the 5 questions of this survey. We need this information by the end of August, so please take a moment to click through to this survey right now. Answering the 5 questions will take less than one minute. Every U.S. patient can participate in the Research Network; you do not have to be a member of any organization to participate. If you have already answered the survey, thank you. You do not need to do so again.

The historical approach of the U.S. Centers for Disease Control and Prevention (CDC) to the study of ME/CFS has not been universally well-received – and that’s an understatement. The majority opinion of the ME/CFS community seems to be that the CDC has had its head stuck in the sand, as far as ME/CFS is concerned, ever since CDC epidemiologists finally rolled into Lake Tahoe to investigate the outbreak there in 1984. But in recent years there have been some promising signs that the CDC may at last be starting to take the disease more seriously.

The CDC’s multi-site, multi-phase clinical assessment study aims to “describe the differences and similarities among CFS patients,” “improve how we measure illness domains of CFS,” “address the CFS case definition,” and possibly allow patients “to be sub-grouped to improve therapy and allow the underlying biology to be discovered.”

Such a large study, led by a federal agency, represents a major opportunity for patients, both in the United States and around the world. There is at least a chance that it might bring some much-needed clarity to the questions and problems surrounding case definitions and subsets which have dogged ME/CFS research for decades.

So, it’s a very important study for ME/CFS patients, and it’s important too for the credibility of the CDC, so badly damaged in the eyes of the patient community by the scandal over the diversion of funds allocated for ME/CFS research – not to mention more than 25 years of failure to make meaningful progress in the study of an illness that blights the lives of millions of patients. The CDC study is already collecting a mountain of data, but in conducting research the answers you find depend on the questions you ask, and the data you collect. And there, it appears, we may have a problem.

Missing Information

Although the study has already collected a vast array of data on clinical history and demographics, and patients have filled in a long list of questionnaires, so far there’s been a worrying lack of tests that could help confirm biological abnormalities in ME/CFS patients. More worrying still, at the last CFSAC meeting in May 2013, Dr Unger appeared to indicate resistance to the idea of conducting the very tests that many consider crucial to understanding the nature of the pathology in ME/CFS.

Repeat exercise testing is considered by many to be the fundamental test necessary to confirm post-a study of CPET abnormalities, and both Keller and Vemeulen have also confirmed what many practitioners and patients know from long experience: repeat testing is necessary to demonstrate the distinctive effects of exercise on ME/CFS patients. This finding may be in tune with patients’ subjective experiences, but it does need further confirmation in larger studies. What better opportunity than the CDC’s large-scale study to explore this crucial question?

Post-exertional malaise is widely seen as the cardinal symptom of ME/CFS – but is the CDC prepared to conduct the tests necessary to demonstrate it, or will it deploy other tests that are known to miss this crucial phenomenon? Dr. Chris Snell recently conducted a study of CPET abnormalities, and both Keller and Vemeulen have also confirmed what many practitioners and patients know from long experience: repeat testing is necessary to demonstrate the distinctive effects of exercise on ME/CFS patients. This finding may be in tune with patients’ subjective experiences, but it does need further confirmation in larger studies. What better opportunity than the CDC’s large-scale study to explore this crucial question?

A wealth of research has also highlighted the significance of viral infections and immune dysfunction in ME/CFS, but will the CDC even measure NK [natural killer] Cell Function and test for viruses associated with ME/CFS?

It is far from clear that the CDC intends to ask any of these questions: the detail so far on the promised blood testing seems vague at best. And with the CDC having already admitted that their study has not yet found a way to include any of the most severely affected housebound and bedbound patients, there’s a considerable risk that the CDC’s study may fail to examine ME at all – a frightening prospect if its conclusions are going to be interpreted and applied as if they had done so.What hope is there for a useful outcome from this study if the CDC fails to assess the most promising candidates for biomarkers discovered in the last 20 years of ME/CFS research? What chance that the research will help to restore common understanding to a fractured field if it excludes the most promising tests indicated by the work of ME/CFS researchers? Do the study’s findings, and any recommendations for case criteria which may result from it, have a realistic chance of being respected and accepted, rather than opposed by the patient and advocacy community if the study fails to ask the very questions that many patients, advocates and researchers consider to be the most crucial?

The danger that this study may become yet another missed opportunity – or worse, bury the reality of a serious illness even deeper below a mountain of obfuscation – seems very real to many advocates, who are disturbed by the apparent intention of the CDC to exclude crucial evidence from the study.

Letter to the CDC

With these concerns in mind, on July 22nd, 11 patient organizations (including Phoenix Rising) and 31 patient advocates wrote to Dr. Unger, Secretary Sebelius, Dr. Koh, Dr. Frieden, the sites participating in the CDC study and their clinicians, and the members of CFSAC, urging them not to rely on self-reported measures but to include objective measurements in their study. Specifically, the letter calls for the inclusion of 2-day Cardiopulmonary Exercise Testing or CPET (using the Stevens Protocol) and laboratory tests to measure Natural Killer Cell function and viral load, including enteroviruses.

The letter includes an extract from the CFS Advisory Committee meeting of May 2013, reminding Dr. Unger of the testimony of Fred Friedberg that post-exertional malaise is “uniquely important” in the essence of this illness, and of Steve Krafchick who said that he would “get down on his knees and plead” with Dr. Unger for the integration of neuro-psych testing and CPET into the study because it represents “the most objective evidence that you could ever hope to get”, adding: “patient report is nice, and it’s cheap, but if we’re trying to do what you said you were trying to do – don’t miss this opportunity please.”

Also included with the letter are academic references in support of the call for the use of CPET, and the list of organizations and advocates who signed it. You can read the letter and supporting information here, and the letter sent to clinicians is available here.

The letter’s conclusion sums up its message: “Objective, biological measurements are vital in order to describe the differences and similarities among patients, determine how we characterize and treat patients, address the case definition issues, educate our medical community, and further our understanding of the underlying biology of ‘CFS’. For that reason, we urge you to consider incorporating these important tests as soon as possible”.

“Please know that we are willing to do everything within our power to work with you and the clinicians involved in order to accomplish this crucial goal. Like you and your colleagues, we want this study to be a success.”So: A wide range of organizations and patient advocates have spoken. Over now to Dr. Unger and the CDC: are they prepared to test ME/CFS patients for biological abnormalities, or are their heads still stuck firmly in the sand?

How to Add Your Voice

Eleven organizations and 31 patient advocates have spoken – now we urge the wider ME/CFS community, including non-U.S. residents, to add their voice and add to the pressure on the CDC to include these objective measurements in their study.

Erica Verrillo has produced the following template letter – a shorter version of the letter already sent to Dr. Unger – which you can use to add your voice in support of this campaign. Please feel free to edit it and add your own comment.(Simply highlight the letter, copy, and paste it into an email.)

In 2012, the CDC initiated a multi-site, multi-phase clinical assessment study to describe the differences and similarities among ME/CFS patients, determine how we characterize and treat patients, implement an accurate case definition, educate our medical community, and further our understanding of the underlying biology of ME/CFS.

Because the CDC’s multi-site study represents a major opportunity to make a difference for patients – both in the United States and around the world – objective, biological measurements are vital. However, a clinical investigation that does not include proper methodology to obtain objective data will fail to achieve its goals and will result in lost time, lost investment, and worst of all, lost opportunity.It is absolutely essential that the CDC study include two objective tests which have consistently revealed abnormalities in ME/CFS patients. These tests are:

The two-day Cardiopulmonary Exercise Test (CPET). The two-day CPET provides gas exchange and other objective and measurable results “which can’t be faked.” Numerous studies have shown that the 2-day CPET – as opposed to the 1-day CPET – is a reliable and consistent method for measuring post-exertional malaise (PEM), the hallmark symptom of ME/CFS. This test can be done employing technology which has been used in hospitals for decades.Low Natural Killer Cell Function/Viral Load. Abnormally low NK Cell activity and high viral loads are consistent findings in patients with ME/CFS. These tests can be done in many labs around the country and will provide objective, measurable data for comparison purposes.

Measuring and understanding post-exertional malaise (PEM) is crucial to this study. PEM is not only the primary symptom that distinguishes ME/CFS from depression, deconditioning, and other fatiguing illnesses, it is the ME/CFS sufferer’s main obstacle to daily activities, gainful employment, and leading a normal life.

Please include the 2-day CPET and tests for NK-Cell function and viral load in the CDC’s multi-site study.

Only the Aussies!Fearless Trio Wearing Beard Beanies Tackles Mongol Rally for CharityPress Release: Los Angeles, CA, August 04, 2013 --(PR.com)-- Beard Head, Inc. is thrilled to announce that it is sponsoring the Machiniacs team at this year’s 2013 Mongol Rally, a pan-continental 10,000 mile roadtrip for charity. The team will wear Beard Head beanies throughout the 12-week journey from the United Kingdom to Mongolia and back.“Our team was immediately struck by Beard Head’s wonderful mix of playfulness and practicality,” team VP Loren Adams said. “The Mongol Rally is a conquest - so it seems appropriate to warm our faces with Barbarian-esque Beard Head beanies.”The team has pledged to raise money for Cool Earth and for ME/CFS Australia, an organization dedicated to beating Myalgic Encephalomyelitis (ME) and Chronic Fatigue Syndrome (CFS). ME/CFS is a severe, acquired illness related to the dysfunction of the brain, gastrointestinal, immune, endocrine, and cardiac systems.“We’re excited to help support a journey that is inspiring in so many ways,” said David Stankunas, President of Beard Head, Inc. “The Mongol Rally embodies the sense of adventure and bravery that Beard Head is all about.”Loren Adams was diagnosed with ME/CFS two years ago. Her diagnosis and recovery motivated her to embark on the challenging Mongol Rally voyage.“We hope that completion of such an ambitious journey will stand as a reassuring message for people currently suffering from this debilitating illness,” Ms. Adams said.The team is driving the “Can-Do Kangaroo,” a 2003 Renault Kangaroo covered with Beard Head-inspired artwork. Live coverage of their trek can be found at: machiniacs.org and theadventurists.com.

Please take advantage of this unprecedented opportunity to make your voice heard.

The FDA will still accept comments from patients, even though the deadline has passed.In the recent newsletter (July 27) we noted that Friday, August 2 was the deadline for submitting comments to the FDA’s Drug Development for Chronic Fatigue Syndrome and Myalgic Encephalomyelitis; Public Workshop.However on Friday the FDA’s server was unavailable for most of the day, and several of you notified us that you were unable to submit your comments. Thanks to great research detective work by one of you, we have reached the person at FDA responsible for dockets, and he has agreed that they will continue to accept comments for the docket by mail or fax. He assured me that all comments are read, so this is not a useless exercise! If you have something to say, please say it. Comments can be brief, and should address any of the points below. Be sure to include the docket # with your comments.The mailing address is:

Patients and advocates unfortunately have good reason to be disappointed in the lack of government action on this illness, but the FDA is an exception and is working actively to help. Now we need to HELP THE FDA HELP US.

How you can help - tell the FDA your story

The first day of the meeting "focused exclusively on gathering patients’ perspective. FDA heard directly from patients about their experiences with this debilitating condition. Discussion focused on two key topics: 1) disease symptoms and daily impacts that matter most to patients, and 2) the patient perspective on treatment of this condition." This portion of the meeting "provided a particularly valuable opportunity for FDA to hear in patients’ own words about how they experience their disease." Hearing the stories directly from patients was apparently eye-opening to the FDA.

Please add your voice - the FDA is listening!! Even if you think your experience is common to many patients, and you are bored with re-telling it, it will be very valuable to share in this forum. Giving specific, seemingly mundane details is especially helpful to the FDA. Talk about the symptoms you experience and how they affect your life. Describe what helps you get from day to day, and how much (or little) it helps. What is your life like when you feel "better"? How can you tell if a treatment is working?Thank you for taking a few minutes to do this. You will be helping all patients.

The unstated rationale for the reclassification is that because these conditions don't fit into a medical "cookbook," a single psychiatric diagnosis would relieve physicians of the onerous task of spending the time required (i.e. more than 10 minutes) to diagnose and treat these patients. In short, patients with "unexplained" illnesses could now be shunted off to a therapist - therapy being less costly than extended visits, extensive testing, and expensive treatment.The diagnosis of "bodily distress syndrome" has as much scientific validity as "possession by evil spirits." But that has not prevented Danish agencies from adopting "bodily distress syndrome" as a legitimate diagnosis. This "diagnosis" provided the grounds for removing Karina Hansen from her home in February 2013 to a psychiatric hospital, for revoking her right to legal representation, for enforcing "evidence-based care" (exercise and cognitive behavioral therapy), and for prohibiting visits from her parents. (Below is the abstract of the Fink and Schröder study.)

BACKGROUND: In order to clarify the classification of physical complaints not attributable to verifiable, conventionally defined diseases, a new diagnosis of bodily distress syndrome was introduced. The aim of this study was to test if patients diagnosed with one of six different functional somatic syndromes or a DSM-IV somatoform disorder characterized by physical symptoms were captured by the new diagnosis.

METHOD: A stratified sample of 978 consecutive patients from neurological (n=120) and medical (n=157) departments and from primary care (n=701) was examined applying post-hoc diagnoses based on the Schedules for Clinical Assessment in Neuropsychiatry diagnostic instrument. Diagnoses were assigned only to clinically relevant cases, i.e., patients with impairing illness.RESULTS: Bodily distress syndrome included all patients with fibromyalgia (n=58); chronic fatigue syndrome (n=54) and hyperventilation syndrome (n=49); 98% of those with irritable bowel syndrome (n=43); and at least 90% of patients with noncardiac chest pain (n=129), pain syndrome (n=130), or any somatoform disorder (n=178). The overall agreement of bodily distress syndrome with any of these diagnostic categories was 95% (95% CI 93.1-96.0; kappa 0.86, P<.0001). Symptom profiles of bodily distress syndrome organ subtypes were similar to those of the corresponding functional somatic syndromes with diagnostic agreement ranging from 90% to 95%.CONCLUSION: Bodily distress syndrome seem to cover most of the relevant "somatoform" or "functional" syndromes presenting with physical symptoms, not explained by well-recognized medical illness, thereby offering a common ground for the understanding of functional somatic symptoms. This may help unifying research efforts across medical disciplines and facilitate delivery of evidence-based care.

By Simon Lawrence'I am a ghost in the land of the living – forgotten, ignored and drifting on the edges of life, whispering my message in the ears of the lucky ones who can participate in life. I have Myalgic Encephalomyelitis. I call it paralysis, muscle and cardiac failure, brain injury, a living plague that kills only slowly, but does kill..." ~Aylwin (Jennifer) Catchpole, who died in August 2010Why have an Understanding and Remembrance Day highlighting the plight of the severely affected?The severity of this illness often makes it impossible for people to have contact with loved ones, doctors, or the outside world. This is a group of thousands of people in the UK who are generally invisible. People with the severe forms of this disease can no longer pursue their careers, hobbies, or everyday lives.In helping us to make visible the stories of people living with severe M.E., and of those who have died as a result of the illness, you can help end years of misrepresentation about M.E. and increase the understanding of the general public, who often underestimate the seriousness of the disease.This ignorance causes much suffering to those with M.E., who have a double battle, not only with the disease itself, but also to get the illness taken seriously by those around them. There is an urgent need to raise awareness.What's the significance of 8th August?This is the birth date of Sophia Mirza. Sophia was bed-bound with severe Myalgic Encephalomyelitis and was a victim of medical abuse.Her doctors did not believe that Myalgic Encephalomyelitis was a physical disease and so she was forcibly taken from her bed/home by social workers, police officers and doctors, and kept in a psychiatric facility where she received inappropriate treatment and care.Sophia subsequently died of M.E. at the age of 32.Her post-mortem revealed widespread inflammation in the spinal cord. This same inexcusable abuse still goes on.

Emily Collingridge - 17th April 1981 - 18th March 2012“When our daughter, Emily, died in 2012, my husband and I were overwhelmed by the hundreds of messages of sympathy we received, even from people we did not know.They came from friends, from those expressing gratitude for her endless campaigning to spread awareness of ME and from readers of her guide to living with severe M.E., many of whom said it had changed their lives.”The inquest into Emily’s death took place on 24th May 2013. In her summary the Coroner referred to ME as a condition which is not understood, and expressed the need for more research.She was echoing an appeal made by Emily in 2011 highlighting what she described as “the scandalous lack of research into the most severe form of M.E. and the lack of appropriate support for those suffering from it.”A final plea in Emily’s own words: “Please put an end to the abandonment of people with severe ME and give us all real reason to hope”.Emily may have lost her personal battle, but her battle on behalf of all those still suffering from severe ME should not be ignored.What is Myalgic Encephalomyelitis?Myalgic Encephalomyelitis literally means muscle pain (myalgia) with brain and spinal cord inflammation (encephalomyelitis). It is a complex neurological illness.The most characteristic distinguishing feature is that symptoms are exacerbated by activity and sensory stimuli beyond the patient's limitations.Activities that trigger flare-ups can be tiny by healthy standards, depending on the severity of the illness. Simple things like talking, watching a TV programme, or eating a meal, can cause an exacerbation.Dysfunction has been found in all the major systems - neurological, immune, endocrine, cardiovascular, musculoskeletal, gastrointestinal, respiratory, and genito-urinary, which is why people with Myalgic Encephalomyelitis can have such a wide range of symptoms.Common symptoms include widespread pain, cognitive dysfunctions (e.g. problems with concentration and memory), disabling sensitivities to everyday stimuli (such as light and noise), difficulty being upright (including sitting up in bed), sleep disorders and gastrointestinal problems.You can read Sophia's story here: www.sophiaandme.org.ukHer story also features powerfully in the film 'Voices from the Shadows' which is available from: www.voicesfromtheshadowsfilm.co.ukEmily also wrote an informative book entitled: "Severe ME/CFS: A Guide to Living' which can be found at: www.severeme.infoFurther website information can be found at: http://tinyurl.com/oasltvyThe parents of those mentioned in this Press Release are happy to be contacted by members of the Media. This can be arranged through contacting the 25% ME Group, (the national support group for severely affected ME Sufferers).Contact details below:25% ME GROUP21 CHURCH STREETTROONAYRSHIRE, KA10 6HTTel: 01292 318 611www.25megroup.orgE-MAIL: enquiry@25megroup.org

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About me:I'm a 25-year veteran of CFIDS. I know what it is like to be bedbound for long stretches of time. I also know what it is like to recover, and to relapse. But this blog is not about my personal experience. It is intended to be a resource - a collection of anything that might be helpful to the CFIDS community: book reviews, advice, CFIDS news, research, advocacy, opinion, who's who in our community, fundraising... and occasionally a bit of humor.

Disclaimer: I am not a doctor, which means nothing I write, no matter how sensible it may be, should be interpreted as medical advice.